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Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy (QUANTI-SUV)

Primary Purpose

Cardiac Amyloidosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bone scintigraphy
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient, male or female, over 18 years of age
  • Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy
  • Patient with signed consent

Exclusion Criteria:

  • Patients with systemic AL amyloidosis
  • Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding woman

Sites / Locations

  • Hôpital privé Le BoisRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with transthyretin related cardiac amyloidosis

Arm Description

Bone scintigraphy

Outcomes

Primary Outcome Measures

Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy

Secondary Outcome Measures

Full Information

First Posted
April 15, 2021
Last Updated
April 22, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT04849754
Brief Title
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy
Acronym
QUANTI-SUV
Official Title
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy for the Follow-up of Patients With Transthyretin Amyloidosis Treated With Tafamidis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Recently, treatment with tafamidis in patients with cardiac ATTR lead to a significant reduction in mortality. The Perugini score is commonly used on planar bone scans to differentiate cardiac ATTR from other amyloidosis or normal patients but fails to evaluate amyloid burden and patient prognosis. Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.
Detailed Description
Cardiac amyloidosis is a cause of restrictive cardiomyopathy with preserved ejection fraction associated with amyloid fibrils deposits in the myocardium. Two types of amyloid commonly infiltrate the heart: immunoglobulin light-chain amyloid (AL), and transthyretin-related amyloid amyloidosis (ATTR). Cardiac imaging is currently used for the diagnosis of ATTR, including planar scintigraphy with bone seeking radiopharmaceuticals, cardiac magnetic resonance and echocardiography with global longitudinal strain assessment.Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with transthyretin related cardiac amyloidosis
Arm Type
Other
Arm Description
Bone scintigraphy
Intervention Type
Diagnostic Test
Intervention Name(s)
bone scintigraphy
Intervention Description
Bone scintigraphy
Primary Outcome Measure Information:
Title
Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient, male or female, over 18 years of age Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy Patient with signed consent Exclusion Criteria: Patients with systemic AL amyloidosis Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision Pregnant or breastfeeding woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic MOUQUET
Phone
0642377375
Email
fmouquet@ovh.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredric MOUQUET
Organizational Affiliation
Hôpital Privé Le Bois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital privé Le Bois
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Mouquet
Phone
0642377375
Email
fmouquet@ovh.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy

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